REACH & CLP

Substances of Very High Concern (abbreviated as SVHC) are identified as such where, at a minimum:

• substances meet the criteria for classification in the hazard class:
  
  • carcinogenicity category 1A or 1B
    germ cell mutagenic category 1A or 1B
    toxic to reproduction category 1A or 1B
    harmful effects on reproduction (CMR)
    
• substances are persistent, bioaccumulative, toxic (PBT)
• substances are highly imperishable and showing high bioaccumulative abilities (vPvB)

Candidate List

The Candidate List is a list, managed by ECHA and published on its website, of that part of substances referred to as SVHCs, for which an appropriate procedure has been initiated to identify substances meeting the above criteria, ended with unanimous acceptance by the Member State Committee (MSC) - inclusion of the substance in Candidate List is the first step in the possible authorization of a substance.

As a result of the inclusion of a substance in the Candidate List, companies with the roles of supplier, importer have certain obligations not only for these substances on their own, but also for mixtures and articles containing this substance, as described below:

• substance on its own

from the date of inclusion of the substance in the Candidate List, each supplier/importer of the substance mentioned above must provide the recipient with a safety data sheet.

• substance as a component of a mixture

from the date of inclusion of the substance in the Candidate List, each supplier/importer of a mixture not classified as dangerous (according to Directive 1999/45/EC), containing at least one substance from the Candidate List in a concentration ≥ 0.1% w/w. for non-gas mixtures and at a concentration of ≥ 0.2% by volume for gaseous mixtures, must provide the customer, upon request, with a safety data sheet.

• substance in the article

each supplier/importer of an article containing a substance on the Candidate List in a concentration > 0.1% w/w must provide the recipient of the article with sufficient information (at his disposal) or make it available free of charge at the consumer's request, within 45 days of receiving the relevant request. This information should include instructions for safe use of the device and/or at least the name of the substance.

The first candidate list was published by ECHA on 20/10/2008; The Agency has now adopted the policy of updating the list twice a year, in June and December.

Specific requirements for substances in articles. If articles contain a Candidate List substance, this may result in additional obligations to those already listed for companies producing, importing and importing such articles.

A particularly important requirement is the obligation to notify (notify), which consists in submitting to the Agency (ECHA) specific information on substances and their use in articles, as well as on the use of the article. Substance notification is required if all of the following conditions are met:

• the substance is on the Candidate List
• the substance is present in manufactured or imported articles in a concentration higher than 0.1% w/w.
• the total amount of the substance present in all manufactured or imported articles in a concentration higher than 0.1% by weight, exceeds 1 tonne per year per manufacturer/importer.

Notifying substances in articles to the Agency is the responsibility of article producers/importers (Article 7 (2) of the REACH Regulation), and providing information in this regard is the responsibility of the supplier (Article 33 of the REACH Regulation).